Supporting the Future of Immunomodulatory Drugs
Achieve Critical Milestones in Your Drug Development Program
At Altasciences, we specialize in diverse immunomodulators, including proteins, oligonucleotides, biologics, bispecific antibodies, and gene therapy.
Our evaluations count on essential biomarkers, like cytokines, complement factors, immune cell subtyping, and functional measurements.
Rely on us for:
- precise drug quantitation and biomarker assessment;
- state-of-the-art bioanalytical platforms to monitor multiple aspects of immunomodulation in various species;
- bioanalytical teams with relevant experience handling pathogens and working with infectious samples for your vaccine development programs; and
- labs equipped with containment Level 2 (CL2) areas for handling pathogens within the Risk Group 2.
Need more guidance? Send us a message.
You may also be interested in the below resources:
Fact Sheet: Immunogenicity Testing
eBook: Key Biomarkers of Immunomodulation
Webpage: Bioanalytical Platforms
A Closer Look At Our On-Site Compounding Pharmacies
Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards.
What you can expect:
Cutting-Edge Facilities
- USP 797 certified clean rooms with Class II biological safety cabinets.
- Negative pressure, HEPA-filtered extemporaneous compounding rooms equipped with the advanced PowderSafe™ ductless balance enclosure, guaranteeing sterile and controlled environments for multiple dosage forms.
- Electronic security access to the pharmacy and video monitoring.
- 24/7 monitoring of temperature and humidity.
Regulatory Excellence
- Licenses for Schedule I through IV drug substances.
- Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units.
- Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.
Comprehensive Capabilities
- Extensive experience in extemporaneous and intravenous preparation, including biologics.
- Fully equipped to support all types of IP administration forms.
Clinical Supply Manufacturing
Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.
You may also be interested in the following webpages:
Pharmaceutical CDMO and Contract Manufacturing Services
DID YOU KNOW?
Our CDMO team offers formulation development and manufacturing of your API, from discovery through commercialization. We also provide analytical testing, ICH stability storage and testing, as well as finished product and release testing. We can manufacture almost every dosage form on the market.
Get Improved Bioavailability and Stability With This Dosage Form
The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations. Taking those factors into account, liquid-filled, hard-shell capsules (LFHCs) offer several advantages compared to other traditional solid oral dosage forms, such as:
• improved solubility and bioavailability
• enhanced stability
• customizable release profiles
• flexibility of formulation
• faster onset of action
• potential for combination therapies
• improved patient compliance in clinical trials
To learn more about the application of LFHCs in drug development, and how they can accelerate your timeline, consult the resources below.
eBook: The Applications of Liquid-Filled Capsules in Pharmaceutical Development
Interview: Benefits of Using Liquid-Filled Capsules in Clinical Trials
Case Study: Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol
To find out if your compound is suitable for LFHCs, speak with one of our experts today.
Preclinical Resource Library
A Wealth of Information at Your Fingertips
Altasciences has an extensive understanding and decades of experience in IND/NDA-enabling toxicology, safety pharmacology, and laboratory services that meet global regulatory requirements.
Here are some of our most insightful scientific resources in preclinical development to guide you through every step of the journey:
- Webinars that cover topics related to the potential of miniature swine in preclinical studies, insights for avoiding common pitfalls in early drug development, and effective interpretation of toxicity data for classification.
- The Altascientist — A Scientific Journal that offers insights into the evolving role of miniature swine in preclinical safety studies, effective safety pharmacology practices, and valuable tips for planning successful preclinical assessments to support regulatory submissions.
- eBooks that help you navigate the preclinical regulatory process, identify key milestones for accelerated drug development, and delve into dermal testing solutions.
Speak with an expert today to learn more about our preclinical solution.
Have five more minutes? Check out these web pages:
Preclinical Services
Miniature Swine in Nonclinical Studies
In Case You Missed It: Webinar on Safety Assessment of Gene Therapy Products
If you missed our latest webinar titled Nonclinical Safety Assessment of Gene Therapy Products, it’s not too late! The on-demand version is now available.
Topics covered include:
• current trends in the development of gene therapy products;
• timing of biodistribution studies based on the ICH S12 Guideline;
• planning considerations and requirements for toxicity studies; and
• AAVs NAbs pre-dose screening data for animal selection.
If you have questions about your nonclinical cell and gene therapy studies, speak with one of our experts.
You may also be interested in:
eBook: Key Considerations for Cell and Gene Therapy Nonclinical Studies
Scientific Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors
Scientific Journal: Applications of PCR Analysis for Your Gene Therapy Programs